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Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001)

NCT04033068 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-12-06

Study results available
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Summary

This study is designed to investigate, at first, safety and tolerability of a novel liquid vaccine formulation named MV-ZIKA-RSP, in healthy adults aged 18 to 55 years

Conditions

  • Zika Virus Infection

Interventions

BIOLOGICAL

Two MV-ZIKA-RSP vaccinations (high dose)

In this arm of the study, 14 participants will receive: 1. V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose). 2. V2= day 28; dose vaccination with MV-ZIKA-RSP (high dose). Description: Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (high dose) Visit 2: Participants will receive their second vaccination with MV-ZIKA-RSP (high dose)

BIOLOGICAL

Two MV-ZIKA-RSP vaccination (low dose)

In this arm of the study, 14 participants will receive: 1. V1= day 0; dose vaccination with MV-ZIKA-RSP (low dose). 2. V2= day 28; dose vaccination with MV-ZIKA-RSP (low dose). Description: Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (low dose) Visit 2: Participants will receive their second vaccination with MV-ZIKA-RSP (low dose)

BIOLOGICAL

One MV-ZIKA-RSP vaccination (high dose) and one placebo

In this arm of the study, 12 participants will receive: 1. V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose). 2. V2= day 28; treatment with placebo Description: Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (high dose) Visit 2: Participants will receive their second treatment with placebo

OTHER

Two placebo injection

In this arm of the study, 8 participants will receive: 1. V1= day 0; placebo treatment 2. V2= day 28; placebo treatment Description: Visit 1: Participants will receive their first treatment with placebo Visit 2: Participants will receive their second treatment with placebo

Sponsors & Collaborators

  • Themis Bioscience GmbH

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-02
Primary Completion
2020-01-30
Completion
2020-06-10

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04033068 on ClinicalTrials.gov